TRIBENZOR
Details
- Status
- Prescription
- First Approved
- 2010-07-23
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
TRIBENZOR Approval History
What TRIBENZOR Treats
1 FDA approvalsOriginally approved for its first indication in 2010 .
- Other (1)
TRIBENZOR Boxed Warning
FETAL TOXICITY When pregnancy is detected, discontinue Tribenzor as soon as possible. ( 5.1 , 8.1 ) Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus. ( 5.1 , 8.1 ) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue Tribenzor as soon as possible ( 5.1 , 8.1 ). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing f...
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Tribenzor as soon as possible. ( 5.1 , 8.1 ) Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus. ( 5.1 , 8.1 ) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue Tribenzor as soon as possible ( 5.1 , 8.1 ). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.1 , 8.1 ).
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TRIBENZOR FDA Label Details
ProIndications & Usage
FDA Label (PDF)Tribenzor is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Tribenzor. Control of high blood pressure should be part of comprehensive cardiovascular...
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Tribenzor as soon as possible. ( 5.1 , 8.1 ) Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus. ( 5.1 , 8.1 ) WARNING: FETAL TOXICITY See full prescribing information for co...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.